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CT-2106 for the Second Line Treatment of Ovarian Cancer
This study has been completed.
Sponsored by: Cell Therapeutics
Information provided by: Cell Therapeutics
ClinicalTrials.gov Identifier: NCT00291837
  Purpose

The purpose of this sudy is to determine the response rate of CT-2106 in patients with advanced ovarian cancer who have failed one prior platinum and taxane based regimen.


Condition Intervention Phase
Ovarian Cancer
Drug: CT-2106
Phase II

MedlinePlus related topics: Cancer Ovarian Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Phase II Open Label Study of CT-2106 as a Single Agent in Patients With Advanced Metastatic Ovarian Cancer Who Have Failed One Prior Platinum and Taxane Based Regimen

Further study details as provided by Cell Therapeutics:

Primary Outcome Measures:
  • response rate

Secondary Outcome Measures:
  • toxicity
  • response duration
  • time to progression
  • survival

Estimated Enrollment: 40
Study Start Date: November 2004
Study Completion Date: July 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with advanced ovarian carcinoma, who have failed one prior platinum and taxane containing regimen
  • Only one prior chemotherapy containing either cisplatin or carboplatin plus taxanes administered concomitantly
  • At least one measurable lesion according to RECIST
  • ECOG performance status 0 or 1
  • at least 18 years old
  • Adequate haematological function
  • Adequate renal and hepatic functions
  • Normal coagulation parameters

Exclusion Criteria:

  • Platinum-sensitive patients (Group 2) who responded (CR or PR) to a 1st line therapy and subsequently progressed or relapsed after a treatment-free interval of > 12 months
  • Pregnant or lactating patients
  • Prior treatment with camptothecins
  • Presence or history of CNS metastasis or carcinomatous leptomeningitis;
  • Current active infection per investigator assessment;
  • Unresolved bowel obstruction or subobstruction, uncontrolled Crohn's disease or ulcerative colitis;
  • Current history of chronic diarrhea >= grade 1 (CTCAE version 3);
  • Surgery or radiotherapy ≤ 4 weeks before first study treatment. In case of cytoreductive surgery for the progression of the disease, ≤ 2 weeks before the 1st study treatment are allowed;
  • Other uncontrolled, serious illness or medical condition, as determined by the investigator;
  • Concomitant (or within 4 weeks before inclusion) administration of any other experimental drug under investigation;
  • Concurrent treatment with any other anti-cancer therapy;
  • Known HIV positivity or AIDS-related illness;
  • Patients who cannot be regularly followed up for psychological, social, familial or geographic reasons.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00291837

Locations
France
Saint Brieuc, France
Lyon, France
Italy
Campobasso, Italy
United Kingdom
Birmingham, United Kingdom
London, United Kingdom
Surrey, United Kingdom
Newcastle upon Tyne, United Kingdom
Sponsors and Collaborators
Cell Therapeutics
Investigators
Principal Investigator: Hilary Calvert, PhD Newcastle General Hospital
  More Information

Study ID Numbers: CAM203
Study First Received: February 14, 2006
Last Updated: January 14, 2008
ClinicalTrials.gov Identifier: NCT00291837  
Health Authority: United States: Food and Drug Administration

Keywords provided by Cell Therapeutics:
ovarian
CT-2106

Study placed in the following topic categories:
Genital Diseases, Female
Ovarian cancer
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Endocrinopathy
Ovarian Diseases
Taxane
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Adnexal Diseases

ClinicalTrials.gov processed this record on January 16, 2009